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A recent article and editorial in the Annals of Family Medicine criticizing direct-to-consumer (DTC) advertising prompted a strong rebuttal from industry groups.
The FDA’s tentative agreement with drug and biotechnology companies to accept fees in exchange for quicker reviews of direct-to-consumer (DTC) ads is prompting criticism from industry observers who believe the plan is both a conflict of interest and a violation of the First Amendment.
The FDA’s recent warning about serious adverse events involving off-label uses of Genentech’s drug Rituxan is unlikely to have a long-term financial impact on the company, a financial analyst says.
Lawmakers should not interfere with the current off-label prescribing system because doing so would limit patients’ access to the most innovative treatments, a high-ranking FDA official says.
The FDA will conduct two studies to investigate how the context and format of risk information in direct-to-consumer (DTC) print advertisements influence consumers’ understanding of drug risks.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.
Takeda Pharmaceuticals has alerted healthcare providers about the increased risk of fractures related to Actos, Actosplus met and Duetact tablets, used to treat Type 2 diabetes mellitus.
Some courts are placing drug companies in an impossible situation by failing to recognize the FDA’s preemption authority in product labeling cases, the Washington Legal Foundation (WLF) said.
The FDA issued a public health advisory last week warning physicians that use of erythropoiesis-stimulating agents (ESAs) is associated with an increased risk of death and serious life-threatening side effects.
Medical Concepts Development failed to take corrective action to address bioburden levels exceeding action/alert thresholds on its surgical drapes, according to a recent FDA warning letter.